Reported Jan 21, 2015 · Terminated
Philips Expression MR200 MRI Patient Monitoring System.
Invivo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 12151 Research Pkwy · Orlando, FL · 32826-3222
Is this the product you have?
- Philips Expression MR200 MRI Patient Monitoring System.
- Lot codes and dates
- Model No. 866120
- Lot/ Serial Numbers
US33600065US33600066US33600075US33600077US33600078US33600079US33600080US33600081US33600082US33600083US33600084US33600086US33600087US33600088US33600089US33600090US33600091US33600092US33600093US33600094
- Amount recalled
- 20
Where it was sold
Why it was recalled
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
This product could cause temporary or reversible health problems — stop using it.
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